Pharmacokinetic Study Comparing Topical, Rectal, and Oral Quetiapine
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-000896
NCT ID: NCT02131545
Sponsor Protocol Number: 14-000896
About this study
Quetiapine, a second generation antipsychotic, is only available as oral tablets. However, topical and rectal formulations have been produced in compounding pharmacies. There is no data available suggesting that topical or rectal formulations provide serum levels similar to oral medication. In the clinical setting, when oral administration of quetiapine is not possible (for example, when a patient is extremely ill physically or mentally or both), clinicians and pharmacists have collaborated in such cases and have at times had to administer quetiapine compounded in other dosage formulations such as rectal or topical formulations. Despite clinical effectiveness of these "other" formulations, there are no available studies that have investigated blood levels of the drug other than the oral form. The investigators are therefore designing this pharmacokinetic study to evaluate the the systemic absorption of quetiapine in oral, rectal and topical formulations. If the investigators are able to demonstrate detectable levels from rectal and topical quetiapine formulations compared to the oral form, this knowledge will enhance clinical psychiatric practice by providing a more broad route of administration for quetiapine which is a commonly used drug for psychiatric symptoms.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Healthy adult volunteers (18‐65 years old) willing to undergo a general health screen consisting of blood pressure, heart rate, respiratory rate, height, weight, temperature, and electrocardiogram will be identified.
- The below parameters must be met to be consider an adult healthy to volunteer for inclusion in this study:
- Blood pressure less than 160/99 mmHg and greater than 105/50 mmHg
- Heart rate between 50‐100 beats per minutes
- Respiratory rate between 10‐30 breaths per minute
- Temperature between 34 °C and 37.5°F
- Corrected QT interval of < 470 msec
- Liver function tests less than 1.5 times the upper limit of normal
- Estimated creatinine clearance (estimated by Cockcroft Gault formulation) greater than 60 mL/min
- Female participants will complete a urine pregnancy test that must result in a negative finding
Exclusion Criteria:
- Allergy to quetiapine, Lipoderm or polyethylene glycol
- Currently taking quetiapine
- Pregnant, planning to become pregnant or breast feeding
- Over or under 30% of ideal body weight
- History of or active cardiovascular disease (except hypertension meeting the inclusion criteria for blood pressure), severe kidney disease (i.e. needing dialysis), or liver disease
- History of schizophrenia, bipolar disorder, substance use disorders (but excluding nicotine use disorders and stable unipolar depression (See below))
- Unstable unipolar depression, defined as hospitalization for depression within 1 year or changes to an antidepressant regimen within 6 months
- History of seizure or seizure disorder
- Parkinson's disease, Huntington's disease, tardive dyskinesia or other diagnosed movement disorder
- History of/or active hematologic/oncologic illness
- Dementia
- Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome
- History of organ transplant
- History of gastric bypass
- Contraindications for suppository administration
- With Ostomy, chronic diarrhea
- Diabetes, type 1 or type 2
- Prolong corrected QT interval (>470 msec) or history of congenital long QT syndrome
- Open wound(s) or unhealed wound(s) at topical medication application site (anterior forearm)
- Active or latent tuberculous and currently prescribed pharmacotherapy treatments
- QTc prolonging medications:
- Antipsychotics
- Vaughan Williams Class IA, IB, IC, III antiarrhythmics
- Anti-infective agents (excluding topical agents, oral penicillins, oral cephalosporins)
- Antiemetics
- Methadone
- Cisapride
- Cimetidine
- Divalproex sodium/valproic acid
- Tetrabenazine
- Solifenacin
- Tricyclic antidepressants
- Tizanidine
- Fingolimod
-
Increase quetiapine concentrations, not previously mentioned
- Paroxetine
- Fluoxetine
- Fluvoxamine
- Non-dihydropyridine calcium channel blockers (verapamil, diltiazem)
- Tamoxifen
- Cyclosporin (excluding ophthalmic formulation)
- Nefazodone
-
Decrease quetiapine levels, not previously mentioned
- Bosentan
- Carbamazepine
- Glucocorticoids
- Modafinil
- Primidone
- St. John's wort
- Barbiturates
- Phenytoin
- Vulnerable populations will be excluded (i.e. prisoners, wards of the state, emancipated minors, children, pregnant women)
- Inability to receive telephone calls for the purpose of post-intervention follow-up
- Inability or unwillingness of individual to give written informed consent
- Non-English speaking populations
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Jonathan Leung, Pharm.D., R.Ph. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available